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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
510(k) Number K163308
Device Name SMARTO
Applicant
Jeil Medical Corporation
Seoul,  KR 152-728
Applicant Contact JAEHAN PARK
Correspondent
Jeil Medical Corporation
Seoul,  KR 152-728
Correspondent Contact JAEHAN PARK
Regulation Number878.4820
Classification Product Code
KIJ  
Date Received11/23/2016
Decision Date 12/27/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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